How durable is the effect of mirabegron in successfully-treated overactive bladder patients? Analysis of a multicentre study
Authors:
K. Švabík 1; J. Mašata 1; J. Krhut 2; R. Zachoval 3; T. Hanuš 4; M. Halaška 5; A. Martan 1
Authors‘ workplace:
Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. A. Martan, DrSc.
1; Urologická klinika FN, Ostrava, přednosta doc. MUDr. J. Krhut, Ph. D.
2; Urologické oddělení FTN, Praha, primář doc. MUDr. R. Zachoval, Ph. D., MBA
3; Urologická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr T. Hanuš, DrSc.
4; Gynekologicko-porodnická klinika Nemocnice na Bulovce a 1. LF UK, Praha, přednosta prof. MUDr. M. Halaška, DrSc.
5
Published in:
Ceska Gynekol 2018; 83(3): 164-168
Overview
Objective:
Many clinical studies indicate that pharmacologic treatment of overactive bladder (OAB) is considered effective and safe, but in real clinical practice a substantial proportion of patients discontinues the treatment. The reason for discontinuing the treatment most frequently reported is lack of efficacy and/or side effects. A further significant proportion of patients reports that they stopped the treatment because the symptoms disappeared or were resolved. This β3 agonist seems to be crucial in providing comparable efficacy in the OAB treatment and better tolerance in comparison with anticholinergics. Our aim was to investigate the durability of the mirabegron effect in successfully treated OAB patients and to understand more fully what prompts patients to return to the medication. Is this merely a subjective decision, or is it based on objective worsening of the symptoms?
Design:
Analysis of multicentre prospective study.
Settings:
Gynaecology and Obstetric Department First Faculty of Medicine, Charles University and General University Hospital, Prague.
Methods:
This is an analysis of longitudinal multicentre study of OAB mirabegron treatment persistence. After continuing mirabegron treatment for more than 18 months patients were assessed by bladder diary and specific questionnaires. Patients with a UB-VAS score (Urgency Bother Visual Analogue Scale) of 50 or less were asked to stop the mirabegron treatment and restart the treatment any time later if they felt the need. Patients recorded the date of return to medication; they kept a daily bladder diary and filled in the same questionnaires as at the time of medication discontinuation. We provide a comparison of symptoms at the time of mirabegron discontinuation and at the time of mirabegron medication restart.
Results:
206 patients entered the study. 176 females (85%) and 30 males (15%) with mean age 62.9 ± 12.43, BMI ranging from 16.6 to 48.0 (mean 27.2 ± 4.96). After 18 months 126 patients were persisting with mirabegron treatment. 89 patients had UB-VAS score ≤ 50 (89 of 126 patients, i.e. 71%). Those patients were asked to stop the treatment. From the eligible group of 89 patients, 19 patients (21%) were unwilling to stop the treatment and were therefore excluded. There were no significant differences in bladder diary and QoL characteristics between patients who were unwilling to discontinue the treatment and patients who did stop taking the medication. The group who stopping treatment comprised 70 patients. At the time of last follow-up 22 patients (31%) had not restarted the medication, with mean follow-up of 122.6 days. Therapy was restarted by 48 patients (i.e. 69% of 70). The mean time without treatment was 48 days (± 32.0 days), median 53 days. There was significant worsening of OAB symptoms and subjective bother at the time of restarting the medication.
Conclusion:
Subjective bother based on increase number of frequency, urgency, and nycturia causes patients with positive experience to return to mirabegron treatment. Most patients with successfully-treated symptoms of OAB who discontinue treatment can only do so temporarily. A worsening of the symptoms occurs rather rapidly, because 69% of patients with OAB symptoms successfully treated with mirabegron (UB-VAS ≤ 50) are unable to discontinue taking the medication for more than two months.
Keywords:
mirabegron, overactive bladder, treatment efficacy, discontinuing of the treatment
Sources
1. Benner, JS., Nichol, MB., Rovner, ES., et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int, 2010, 105, p. 1276–1282.
2. Brubaker, L., Fanning, K., Goldberg, EL., et al. Predictors of discontinuing overactive bladder medications. BJU Int, 2010, 105, p. 1283–1290.
3. Coyne, KS., Matza, LS., Kopp, Z., Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol, 2006, 49, p. 1079–1086.
4. Duckett, J., Balachandran, A. Tolerability and persistence in a large, prospective case series of women prescribed mirabegron. Int Urogynecol J, 2016.
5. Haylen, BT., de Ridder, D., Freeman, RM., et al. International Urogynecological, and S. International Continence, An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn, 2010, 29, p. 4–20.
6. Chancellor, MB., Migliaccio-Walle, K., Bramley, TJ., et al. Long-term patterns of use and treatment failure with anticholinergic agents for overactive bladder. Clin Ther, 2013, 35, p. 1744–1751.
7. Choo, MS., Song, C., Kim, JH., et al. Changes in overactive bladder symptoms after discontinuation of successful 3-month treatment with an antimuscarinic agent: a prospective trial. J Urol, 2005, 174, p. 201–204.
8. Kim, A., Lee, KS., Kim, TB., et al. Incidence and risk factors of recurrence of overactive bladder symptoms after discontinuation of successful medical treatment. Investig Clin Urol, 2017, 58, p. 42–47.
9. Lee, YS., Choo, MS., Lee, JY., et al. Symptom change after discontinuation of successful antimuscarinic treatment in patients with overactive bladder symptoms: a randomised, multicentre trial. Int J Clin Pract, 2011, 65, p. 997–1004.
10. Martan, A., Horčička, L., Hanuš, T., et al. Prevalence hyperaktivního měchýře u žen v České republice. Čes Gynek, 2011, 76, s. 144–150.
11. Martan, A., Mašata, J., Krhut, J., et al. Persistence in the treatment of overactive bladder syndrome (OAB) with mirabegron in a multicenter clinical study. Eur J Obstet Gynecol Reprod Biol, 2017, 210, p. 247–250.
12. Sackett, DL. The hypertensive patient: 5. Compliance with therapy. Can Med Assoc J, 1979, 121, p. 259–261.
13. Švabík, K., Krhut, J., Finsterle, V., Martan, A. Perzistence užívání léčby hyperaktivního močového měchýře v České republice. Čes Gynek, 2013, 78, s. 252–256.
14. Švabík, K., Mašata, J., Krhut, J., et al. Stupeň spokojenosti pacientů pokračujících v léčbě hyperaktivního močového měchýře Mirabegronem [Degree of satisfaction of patients continuing overactive bladder treatment with mirabegron]. Čes Gynek, 2017, 82, s. 48–52.
15. Vermeire, E., Hearnshaw, H., Van Royen, P., Denekens, J. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther, 2001, 26, p. 331–342.
16. Yeaw, J., Benner, JS., Walt, JG., et al. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm, 2009, 15, p. 728–740.
Labels
Paediatric gynaecology Gynaecology and obstetrics Reproduction medicineArticle was published in
Czech Gynaecology
![Issue 3](https://www.prolekare.cz/media/cache/resolve/journal_issue/media/image/6035c93addd1afa030d0bd3f24afaceb.jpeg)
2018 Issue 3
Most read in this issue
- Prolactin and alteration of fertility
- Does EmbryoGlue transfer medium affect embryo transfer success rate?
- Vaccination against HPV and view of new possibilities
- Planned home births in the Czech Republic, 2018